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January 21, 2013News for the food and drug law community

  Drugs & Biologics 
  • 6 states consider bills regarding biosimilars
    Six states could consider bills involving the interchangability of biosimilars and brand-name biologics. In Virginia, a legislative panel endorsed a bill that would authorize pharmacists to dispense biosimilars that the FDA considers interchangeable, while a Pennsylvania lawmaker says rules on generics aren't applicable to biosimilars and new legislation is needed. In 2012, changes were proposed to Illinois' Pharmacy Practice Act, while Indiana, North Dakota and Texas also are considering bills. Blog (1/18) Email this Story
  • Treaty omits thimerosal vaccines from effort to curb mercury
    Vaccines containing the ethylmercury preservative thimerosal are exempted from the Minamata Convention's global treaty to limit mercury in the environment. The American Academy of Pediatrics and other groups support thimerosal vaccines, which enable children's access to multidose vaccines in areas without refrigeration. The Washington Times (1/19) Email this Story
7 keys: Put real-world evidence into action
Life sciences organizations need to know how their therapies work in the real world once clinical trials end. And these seven key components to standardizing real-world data and analytics platforms are how they get started. Read the paper, Institutionalizing Real World Evidence.
  Global Focus 
  • St. Jude's stroke prevention device wins approval in Europe
    European regulators have given St. Jude Medical CE mark approval to market its AMPLATZER Amulet Left Atrial Appendage Occluder. The device, patterned after the company's AMPLATZER Cardiac Plug approved in Europe four years ago, is intended to help prevent stroke in patients with non-valvular atrial fibrillation. (1/18) Email this Story
  Food & Dietary Supplements 
  Medical Devices 
  • BD Medical gains FDA approval for drug transfer device
    The FDA has granted BD Medical approval for a device used to make it safe to handle hazardous medications by securing them in a pressure-controlled and sealed system. The technology, called BD PhaSeal Closed System Transfer Device, has demonstrated leakproof and airtight performance in 19 peer-reviewed studies. (1/18) Email this Story
  • Diabetes management systems from Glooko get FDA OK
    Glooko has been cleared by the FDA to market its suite of nonprescription diabetes management systems intended to make it easier to measure food intake, glucometer readings and other key parameters. The clearance applies to the company's MeterSync Cable, Logbook and Logbook Charts applications. (1/18) Email this Story
  Hot Topics 

Top five news stories selected by FDLI SmartBrief readers in the past week.

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  FDLI Items 
  • CFSAN director to keynote -- Food Week early bird savings end Wednesday
    CFSAN Director Michael Landa will give the keynotes address at the Food Safety Conference on Feb 7. FDLI's Food Week 2013 program is a unique opportunity for food law, regulation and policy stakeholders to hear first-hand from government officials and industry experts on the latest legal and regulatory developments. Food Week 2013 is a collection of four advanced one-day conferences, as well as FDLI's industry standard "Introduction to Food Law and Regulation" course. At this unique program, you set the menu -- attend one, two, three or all four conferences to make the most of your Food Week 2013 experience. Email this Story

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